WEBINARS

 

Compliance Training Webinars for Regulated Industries

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BSA Important Issues: new mandates, requirements, and recommendations

webinar-speaker   Justin Muscolino

webinar-time   60 Min

Product Id: 706975

The Bank Secrecy Act (BSA) is a US law that fights money laundering and other financial crimes. BSA requires businesses to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, and regulatory matters. Individuals and financial institutions who fail to comply with BSA requirements may face severe penalties and for more serious offenses, prison sentences.

28 / Jun / 2024 - Friday

* Per Attendee $199

 

Power BI - Data Cleaning and Transformation: From Raw and Poor to Report-Ready

webinar-speaker   Mike Thomas

webinar-time   60 Min

Product Id: 706962

This training is aimed at existing users of Microsoft Power BI who have mastered the basics and want to take their knowledge and learning to the next stage.

8 / Jul / 2024 - Monday

* Per Attendee $199

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Min

Product Id: 705582

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

9 / Jul / 2024 - Tuesday

* Per Attendee $249

 

The GLPs and Analytical Test Methods Validation

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706978

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

10 / Jul / 2024 - Wednesday

* Per Attendee $199

 

NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 - Part 1

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706973

Part 1 -- NEW changes to the Nacha Operating Rules include "minor" Rules changes - effective June 21, 2024 (no major impact on operations but a must know to remain in compliance - by knowing the things they are clarifying in the minor Rule change topics). In addition, Risk Management Topics - effective Oct 1, 2024 (covering topics that were proposed before but now really happening) - such as "Expanded use of Return Reason Codes R06 and R17"; "funds availability exceptions" and "Unauthorized Return changes for the RDFI with timing of the WSUD and returning the unauthorized transaction".

10 / Jul / 2024 - Wednesday

* Per Attendee $199

 

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706884

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.

10 / Jul / 2024 - Wednesday

* Per Attendee $199

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

11 / Jul / 2024 - Thursday

* Per Attendee $299

 

How to Address ISO's New Climate Change Requirements

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 706977

New ISO standards, including ISO 9001, will include additional requirements related to climate change. These fortunately do not involve carbon neutrality goals, but do require organizations to consider climate change and also potential requirements of relevant interested parties.

11 / Jul / 2024 - Thursday

* Per Attendee $199

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

11 / Jul / 2024 - Thursday

* Per Attendee $199

 

How to conduct an effective BSA Audit

webinar-speaker   Justin Muscolino

webinar-time   60 min

Product Id: 706979

BSA rules and regulations must be followed by financial institutions. Although financial institutions have been managing BSA operations in accordance with regulatory requirements, the shift to BSA audits has become increasingly important. Regulators look to the financial institution for confirmation and proof that BSA operations are being audited properly to ensure that BSA efforts are implemented and managed properly.

12 / Jul / 2024 - Friday

* Per Attendee $199

 

US FDA Requirements for Medical Products Labeling / UDI

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706969

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 703792

This webinar will go through every section of the revised FFIEC Bank Secrecy Act/Anti-Money Laundering Examination Manual to highlight changes and areas where banks should review their internal policies, processes and procedures for compliance. Understanding these changes will keep you prepared and updated for your next BSA/AML examination.

17 / Jul / 2024 - Wednesday

* Per Attendee $199

 

The Evolving Landscape for Management of Third Party Service Providers

webinar-speaker   Daniel Clark

webinar-time   60 Min

Product Id: 706980

Third Party Risk Management is all about managing service providers. For several years, businesses have been increasing reliance on third parties. While this reliance has many upsides, there are risks that should be recognized and managed. This session highlights those risks and provides alternatives to best manage them.

17 / Jul / 2024 - Wednesday

* Per Attendee $199

 

NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 – Part 2

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706981

Part 2 – Effective March 20, 2026, two Rule amendments (Fraud Monitoring – Phase 1) – monitoring for Faud (as part of a larger Risk Management package) intended to reduce the incidence of successful fraud attempts and improve the recovery of funds after frauds have occurred.

24 / Jul / 2024 - Wednesday

* Per Attendee $199

 

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 705783

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.

24 / Jul / 2024 - Wednesday

* Per Attendee $199

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

25 / Jul / 2024 - Thursday

* Per Attendee $199

 

FLSA White Collar Exemptions

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706792

This session will review the current Department of Labor regulations as they apply to the white collar exemptions to the minimum wage and overtime requirement of the Fair Labor Standards Act (FLSA). The tests for exemption are the salary basis test, minimum salary requirement, and the duties tests. These tests have changed over the years and are complex and can be confusing. In addition, there are strict record keeping requirements and salary integrity requirements to prevent disqualification of the exemption. The webinar will also describe proposed changes to the rules and how employers can prepare for the changes.

29 / Jul / 2024 - Monday

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

6 / Aug / 2024 - Tuesday

* Per Attendee $249

 

The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

7 / Aug / 2024 - Wednesday

* Per Attendee $199

 

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